Effect of Liver MSCs in Blood of Patients With Liver Disease.
CIRRHOTIQUE01
In Vitro Evaluation of the Effect of HepaStem in the Coagulation Activity in Blood of Patients With Liver Disease.
1 other identifier
observational
9
1 country
1
Brief Summary
Liver MSCs or Adult Derived Human Liver Stem/progenitor Cells (ADHLSCs) infusions are currently being developed as a therapeutic medicinal product for the treatment of different liver defects. Nevertheless, a main concern for clinicians and health authorities is the risk of therapy-induced thrombosis, which has been reported in several patients after intravenous infusion. Previous studies showed in fact that most MSCs express a procoagulant activity. ADHLSCs could be used to treat acute de-compensated cirrhotic patients due to their immunomodulatory and anti-fibrotic effects. However in these patients, disturbances of coagulation and haemostasis are common and result in profound haemostatic alterations that can lead to thrombosis as well as to bleeding complications. The aim of this study is to evaluate the effect of ADHLSCs in cirrhotic blood compared to control blood.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 20, 2017
CompletedFirst Submitted
Initial submission to the registry
August 13, 2018
CompletedFirst Posted
Study publicly available on registry
August 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2019
CompletedMarch 27, 2020
March 1, 2020
12 months
August 13, 2018
March 26, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Blood parameters in tubing loop model
We plan to use the tubing loop model to study the interaction between acute-on-chronic liver failure patient's blood and ADHLSCss. The tubing loop model is a whole blood coagulation in vitro model that mimics the blood flow circulation. It consists of loops made of polyvinyl chloride tubing coated with heparin without any release of heparin in blood. This technique can be used to mimic cell infusion in an in vitro model as close as possible to a patient infusion. Blood parameters are studied after 5 and 60min incubation.
1 day
Fibrin formation in thrombodynamics
The thrombodynamics analyser system records and analyses spatiotemporal dynamics of formation of a fibrin clot in a platelet poor plasma (PPP) sample. We plan to use this model to study the interaction between acute-on-chronic liver failure patient's plasma and ADHLSCss.
1 day
Eligibility Criteria
hospitalised cirrhotic patients in hepatology or intensive care unit
You may qualify if:
- acute de-compensated cirrhotic patients
You may not qualify if:
- anticoagulant treatment except for prophylactic heparin treatment
- coagulopathy
- thrombosis
- cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
Biospecimen
blood plasma
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
August 13, 2018
First Posted
August 15, 2018
Study Start
December 20, 2017
Primary Completion
December 1, 2018
Study Completion
December 30, 2019
Last Updated
March 27, 2020
Record last verified: 2020-03